Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117

Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers

This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.

Study Overview

• Status: Unknown
• Conditions: Drug Interaction Study
• Intervention / Treatment: Drug: Ze 117; Drug: Probe drug cocktail

Detailed Description

Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions.

The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA).

A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neu-Ulm, Germany
    • Nuvisan GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• written informed consent
• Caucasian male or female subjects aged between ≥18 and ≤55years
• Physically and mentally healthy
• BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
• Non-smoker
• If female, the pregnancy test at screening and at admission must be negative

Exclusion Criteria:

• Known or suspected hypersensitivity to study drugs
• history of, any clinically significant diseases
• Positive test of hepatitis B, hepatitis C or HIV Screening
• Known photohypersensitivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probe drug cocktail / Ze 117; One-sequence, Probe drug cocktail alone and in combination with Ze 117.	Drug: Ze 117; Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.; Other Names: St. John's wort dry extract Ze 117; Drug: Probe drug cocktail; Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the Plasma concentration versus time curve (AUC0-t)	Pharmacokinetic Parameter AUC0-t (mg*h/L) of the probe drugs will be determined.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the Plasma concentration versus time curve (AUC0-inf)	Pharmacokinetic parameter (mg*h/L) of the probe drugs and their metabolites will be determined.	72 hours
Peak Plasma Concentration (Cmax)	Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined.	72 hours
Elimination rate constant (Ke)	Pharmacokinetic Parameter (h^-1) of the probe drugs and their metabolites will be determined.	72 hours
Elimination half life (t1/2)	Pharmacokinetic Parameter (h) of the probe drugs and their metabolites will be determined.	72 hours

Collaborators and Investigators

• Sponsor: Max Zeller Soehne AG
• Investigators: Principal Investigator: Michael Lissy, Neu-Ulm

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Anticipated): May 17, 2018
• Study Completion (Anticipated): June 23, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Ze117-1-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No